Adopted on 22 May 2012 and applied for the first time on 1 September 2013, the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) defines the rules for registering new biocides and maintaining the authorised status of existing biocides.
Created to harmonise the European market and facilitate marketing authorisation, Article 3.3 of the EU Biocides Regulation provides a simplified registration procedure for new biocides.
Do you want to sell your biocidal products but do not know how to proceed?
It is true that it is not always easy to understand the regulations and to access reliable and up-to-date information. That’s why we guide you through the European BPR approval process.
The approval
The first step is to approve the active substances contained in the biocidal products in question, before they obtain a marketing authorisation.
To obtain this approval, which is valid for 10 years and renewable, the applicant must first register his application. The applicant is responsible for sending all data on active substances to the competent authority of a Member State. The latter bases its assessment on the hazard classification of the substance and the level of risk it poses to humans and the environment.
The following is a non-exhaustive list of prohibited substances:
- Carcinogens
- Endocrine disruptors
- Persistent and bioaccumulative substances
- Etc.
According to the BPR, these substances are exclusion criteria.
Without banning them, other substances such as quaternary ammoniums, nanomaterials or triclosans are suspected substances by Europe. Moreover, in order to protect health, the SALVECO laboratory does not use these types of substances under any circumstances.
Once analysed, the results are sent to the Biocidal Products Committee of ECHA. Within 270 days, the latter prepares an opinion that will allow the European Commission to approve, or not, the application.
After this first registration, companies can apply to ECHA via R4BP for the desired alternative process (ADM, MA, or BRP transitional regime) by means of a file.
The validation of this dossier requires a mutual recognition process in which a risk assessment and an efficacy test are performed.
These tests attest to:
- The safety of the product
- The stability of the product
They are carried out under real conditions of use, while controlling the environmental and health impacts.
These tests are carried out for:
- Each claimed activity (bactericide, virucide, etc.)
- Each field of application (institutional, industrial, etc.)
- Each type of user (general public or professional)
- Each use of the product (types of surfaces, manual use, etc.).
If validated, the biocidal product can be placed on the market in other European countries without applying for mutual recognition. This is only possible if the authorisation holder informs the Member State concerned.
In general, these procedures take about 1 year, but SALVECO offers you to obtain your SMA in only 6 months.
If you would like to know more about the Simplified Marketing Authorisation at SALVECO, please visit our webpage.
SALVECO, 1st Simplified Marketing Authorisation (SMA) holder in Europe
Because we are aware that these very strict regulations can slow down the marketing of your products, SALVECO offers you a turnkey solution to speed up your business.
Exclusively formulated with 100% plant-based and biodegradable ingredients, the SALVECO laboratory develops safe biocidal products that are not harmful to human health and have no harmful impact on the environment. In addition to ensuring the manufacture of compositions without risk phrases, SALVECO offers a complete regulatory service.
Thanks to the permanent regulatory monitoring carried out by teams of experts, SALVECO is able to support you in the marketing of your biocidal products, from the beginning to the end.
As the leading AMMS holder in Europe, with 130 SMA registered in more than 30 countries, the SALVECO laboratory has a wealth of experience. SALVECO ensures the compliance of your products by anticipating regulatory requirements, new standards set by law (BPR, CLP, REACh, etc.), new labels, market launches, etc. that could affect your business.
Besides mastered know-how and unparalleled speed (6 months), SALVECO is sure to always have a head start to offer you the best!